Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-26 @ 11:45 PM
Study NCT ID:
NCT05541250
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2022-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059348', 'term': 'Peripheral Nerve Injuries'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-related Adverse Events (AEs)', 'timeFrame': 'Up to 2 years', 'description': 'Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician'}], 'secondaryOutcomes': [{'measure': 'Motor Recovery as assessed using the MRC Grading Scale', 'timeFrame': 'Up to 2 years', 'description': 'Motor recovery will be assessed using the Medical Research Council (MRC) Grading Scales. MRC Grading Scale scores ranges from 0-5 with a higher score indicating better function'}, {'measure': 'Sensory recovery as assessed by Pin-Prick Evaluation', 'timeFrame': 'Up to 2 years', 'description': 'Pin prick evaluation will be assessed using the Semmes Weinstein Monofilament Evaluation. Semmes Weinstein Monofilament evaluation has a total score ranging from 0-5 with a higher score indicating better function'}, {'measure': 'Sensory recovery as assessed by the 2-Point Discrimination Evaluation', 'timeFrame': 'Up to 2 years', 'description': '2-Point Discrimination Evaluation scoring ranges from 2-20mm with a higher score indicating worse function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Nerve Injury']}, 'descriptionModule': {'briefSummary': "The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;\n2. Between the ages of 18 and 65 at last birthday\n\nExclusion Criteria:\n\n1. Persons unable to safely undergo an MRI;\n2. Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;\n3. Persons with severe peripheral nerve injury gap length \\> 10 cm;\n4. Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;\n5. Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;\n6. Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;\n7. History of active substance abuse;\n8. Persons allergic to gentamicin;\n9. Persons who test positive for HIV or Hepatitis B or C virus.\n10. Persons unable to provide consent independently due to cognitive impairment'}, 'identificationModule': {'nctId': 'NCT05541250', 'briefTitle': 'Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)', 'orgStudyIdInfo': {'id': '20220447'}, 'secondaryIdInfos': [{'id': 'OR210075', 'type': 'OTHER_GRANT', 'domain': 'United States Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autologous Human Schwann Cell (ahSC) Group', 'description': 'Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant', 'interventionNames': ['Biological: Autologous Human Schwann Cell']}], 'interventions': [{'name': 'Autologous Human Schwann Cell', 'type': 'BIOLOGICAL', 'description': 'A one-time dose of 1000 μl\\* or 80 to 100 million ahSC prepared from segments of the sural nerve from the leg recovered from the participant.', 'armGroupLabels': ['Autologous Human Schwann Cell (ahSC) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'George Jimsheleishvilli, MD', 'role': 'CONTACT', 'email': 'gxj150@med.miami.edu', 'phone': '(305) 2434781'}, {'name': 'Allan Levi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'S. Shelby Burks, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'George Jimsheleishvilli, MD', 'role': 'CONTACT', 'email': 'gxj150@med.miami.edu', 'phone': '(305) 2434781'}], 'overallOfficials': [{'name': 'W. Dalton Dietrich, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W. Dalton Dietrich', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'W. Dalton Dietrich', 'investigatorAffiliation': 'University of Miami'}}}}